Hermetic rotating handle assembly for a surgical clip applier for laparoscopic procedures

ABSTRACT

This invention provides hermetically-sealed handle assembly with a rotating trigger for use with disposable components, such as surgical clip appliers. The rotating trigger reduces the gripping force necessary to fully control the internal actuator mechanism to operate a disposable surgical clip applier to fully ligate a vessel or other tissue. The hermetic seal on the handle assembly prevents any patient fluids and other bioburden from entering the internal structures. This reduces the possibility of cross-contamination and the costs of sterilization.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 61/321,237 filed on Apr. 6, 2010, the contents of whichare incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to a novel hermetic rotating handle assembly fora surgical clip applier for laparoscopic or endoscopic procedures.

BACKGROUND OF INVENTION

Laparoscopic and endoscopic surgical procedures are conducted through asmall incision in the skin or natural body orifices. In order tooperate, surgeons must use instruments that have a small enough crosssection to fit within these small openings and long enough to reach thesurgical area within the body.

Surgical instruments designed for these procedures are often separatedinto two components to reduce costs and minimize cross contamination.

The first component is a long and narrow disposable portion that isinserted into the small opening during surgery. These disposablecomponents contain surgical tools, such as surgical jaws or surgicalclip appliers, dissectors or other instruments, on the end which entersthe patient. These disposable components also contain small actuatorswhich control the operation of the surgical tools within the patient.

These small actuators on the first component are operatively attached tothe second component of these surgical instruments. The second componentis a non-disposable control unit for moving the long disposablecomponent within the patient and operating the actuators to control thesurgical tools on the disposable component. The second component isoften a handle with a trigger. A surgeon may control the movement andplacement of the disposable component by holding the handle and operatethe small actuators by squeezing the trigger. For instance, a surgeonmay squeeze the trigger to place a surgical clip over a vessel.

By separating these two components, the risk of cross contaminationbetween separate patients or separate tissues on the same patient isreduced. The non-disposable control unit does not enter the patient andthe contaminated long and narrow component is simply disposed after eachsurgical procedure is completed. In addition, costs are saved sincemedical providers only need to replace the disposable component betweensurgical procedures.

However, one the problems with currently existing surgical instrumentsused in these procedures is the possible contamination of thenon-disposable control unit. This non-disposable component may stillcontact patient fluids during surgeries and become contaminated. Thismay be especially problematic for handle and trigger assemblies. Inorder for a trigger to be squeezed and moveable, these assemblies haveopenings to their internal structures.

One solution to this problem is for medical providers to autoclave andsterilize each non-disposable component after each surgical procedure.However, the time needed to autoclave and sterilize these non-disposablehandle and trigger assemblies is significantly high due to the need tosterilize the internal structures. This sterilization increasesmaintenance costs for medical providers. Current surgical clip appliersinclude many disposable handles since they cannot be sterilizedeffectively, even with hours in an autoclave.

According, the subject invention is a non-disposable hermetically-sealedhandle assembly with a rotating trigger for use with disposablecomponents, such as surgical clip appliers. The hermetic seal on thehandle assembly prevents any patient fluids and other bioburden fromentering the internal structures. This reduces the possibility ofcross-contamination and the costs of sterilization.

SUMMARY OF THE INVENTION

There are additional features of the invention that will be describedhereinafter and which will form the subject matter of the claimsappended hereto. In this respect, before explaining at least oneembodiment of the invention in detail, it is to be understood that theinvention is not limited in its application to the details ofconstruction and to the arrangements of the components set forth in thefollowing description or illustrated in the drawings. The invention iscapable of other embodiments and of being practiced and carried out invarious ways. Also, it is to be understood that the phraseology andterminology employed herein are for the purpose of the description andshould not be regarded as limiting.

The subject invention discloses an endoscopic surgical tool comprising,a housing comprising an upper portion and a handle; an actuatingmechanism contained within the housing along a first axis, wherein theactuating mechanism is adapted to operatively couple to a disposableexternal shaft that extends away from the housing along a first shaftaxis from a proximal end to a distal end, wherein the first axis and thefirst shaft axis are substantially parallel; a lever coupled at aproximal end to the actuating mechanism and extending in a downwarddirection, wherein the lever is pivotably coupled at a distal end to aninternal shaft that extends along a second shaft axis that issubstantially perpendicular to the first shaft axis; a first end of theinternal shaft extending through a first opening in the housingproximate to the top of the handle, and further extending through acentral opening of a first disc spring; a second end of the internalshaft extending through a second opening in the housing proximate to thetop of the handle, and further extending through a central opening of asecond disc spring, wherein the first opening and the second opening aresubstantially parallel with each other; a first trigger shaft comprisinga first substantially semi-spherical top portion coupled to the firstend of the internal shaft after extending through the first disc spring,wherein the first trigger shaft further comprises a first substantiallyhalf-cylindrical lower portion with a first substantially flat surface,wherein the first disc spring provides a first seal about the first endof the internal shaft by providing a first compressive force on thefirst substantially semi-spherical top portion of the first triggershaft and an opposing second compressive force on the exterior surfaceabout the first opening in the housing; a second trigger shaftcomprising a second substantially semi-spherical top portion coupled tothe second end of the internal shaft after extending through the seconddisc spring, wherein the second trigger shaft further comprises a secondsubstantially half-cylindrical lower portion with a second substantiallyflat surface, wherein the second disc spring provides a second sealabout the second end of the internal shaft by providing a thirdcompressive force on the second substantially semi-spherical top portionof the second trigger shaft and an opposing fourth compressive force onthe exterior surface about the second opening in the housing, whereinthe first and second substantially flat surface of the first and secondtrigger shafts couple to form a substantially cylindrical lower triggershaft defining a longitudinal axis; a hollow substantially cylindricaltrigger grip coupled over the cylindrical lower trigger shaft; whereinapplication of compressive force to the trigger grip towards the handlerotates the cylindrical lower trigger shaft about the longitudinal axisin a first direction to rotate the first and second ends of the internalshaft in a direction away from the second shaft axis, wherein rotationof the internal shaft pivots the coupled lever to operate the actuatingmechanism.

In another embodiment of the subject invention, the first and secondtrigger shafts comprise complementary configurations.

In another embodiment of the subject invention, the external shaftcomprises a cartridge containing surgical clips.

In another embodiment of the subject invention, the distal end of theexternal shaft is adapted to receive an end effector.

In another embodiment of the subject invention, the end effectorcomprises a distally attached surgical jaws assembly.

In another embodiment of the subject invention, the first and seconddisc springs comprise conical spring washers.

In another embodiment of the subject invention, the housing isnon-disposable.

In another embodiment of the subject invention, the cylindrical lowertrigger shaft rotates about the longitudinal axis in a second direction,opposite the first direction, when the trigger is released.

In another embodiment of the subject invention, the housing comprises asingle piece.

In another embodiment of the subject invention, the housing comprisestwo coupled pieces with complementary configurations.

The subject invention also discloses a hermetically sealed handleassembly for a surgical clip applier comprising: a housing comprising anupper portion and a lower handle; an actuating mechanism containedwithin the upper portion of the housing that controls a disposablecartridge containing surgical clips; a shaft extending from the housingcontaining rotating means so as to permit rotation of the shaft about anaxis that extends substantially longitudinally through the shaft,wherein the shaft rotates in a first direction about an axis thatextends substantially longitudinally through the shaft when a grippingforce is applied to the shaft, and further wherein the actuatingmechanism within the housing is coupled to the shaft such that rotationof the shaft operates the actuating mechanism.

There has thus been outlined, rather broadly, the more importantfeatures of the invention in order that the detailed description thereofthat follows may be better understood, and in order that the presentcontribution to the art may be better appreciated. There are additionalfeatures of the invention that will be described hereinafter and whichwill form the subject matter of the claims appended hereto.

These together with other objects of the invention, along with thevarious features of novelty, which characterize the invention, arepointed out with particularity in the claims annexed to and forming apart of this disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present invention will be apparent from the followingdetailed description of embodiments thereof, which description should beconsidered in conjunction with the accompanying drawings, in which:

FIG. 1 illustrates an exploded view of a hermetically-sealed rotatingtrigger and handle assembly for a clip applier.

FIG. 2 illustrates a front view of the hermetically-sealed rotatingtrigger and handle assembly.

FIG. 3 illustrates a side cross-sectional view of thehermetically-sealed rotating trigger and handle assembly along line “A”of FIG. 2.

FIG. 4 illustrates a cross-sectional front internal view of thehermetically-sealed rotating trigger and handle assembly.

FIG. 5 illustrates a side view of the hermetically-sealed rotatingtrigger and handle assembly.

DETAILED DESCRIPTION OF THE EMBODIMENTS

While several variations of the present invention have been illustratedby way of example in particular embodiments, it is apparent that furtherembodiments could be developed within the spirit and scope of thepresent invention, or the inventive concept thereof. However, it is tobe expressly understood that such modifications and adaptations arewithin the spirit and scope of the present invention, and are inclusive,but not limited to the following appended claims as set forth.

FIGS. 1-5 illustrate a hermetically-sealed handle and trigger assembly101 with a handle 102 and a rotating trigger 103 for a surgical clipapplier (not shown). FIG. 3 illustrates a side cross-sectional view ofthe handle and trigger assembly 101 as shown by lines “A” of FIG. 2. Thehermetic seal on the handle and trigger assembly 101 prevents anypatient fluids from entering the internal structures. This reduces thepossibility of cross-contamination and the costs of sterilization, whichallows the handle and trigger assembly 101 to be non-disposable.

The rotating trigger 103 rotates in a first direction that issubstantially perpendicular to the length of the trigger 103 whensqueezed in a direction towards handle 102. The rotating trigger 103rotates in a second direction, opposite the first direction, whenreleased and moving away from handle 102.

The elements of the handle and trigger assembly 101 include an externalhousing 107 that is formed by a hollow left half section 305 and ahollow right half section 306. Hollow left half section 305 and hollowright half section 306 are complementarily shaped to each other. Thehousing 107 may be made of a polycarbonate, ABS, stainless steel orother suitable material known to those skilled in the art. The separatehalf sections 305 and 306 may be attached together by adhesives,fasteners, welding, or other attachment means known to those skilled inthe art.

Left half section 305 has an upper left housing 305 a, a lower lefthalf-handle housing 305 b and a hollow left hinge housing 305 c. Hollowleft hinge housing 305 c has a traversing left opening 305 d.

Right half section 306 has an upper right housing 306 a, a lower righthalf-handle housing 306 b, and a hollow right hinge housing 306 c.Hollow right hinge housing 306 c has a traversing right opening 306 d.

An actuator mechanism 104 is contained within upper left housing 305 aand upper right housing 306 a. Once the left half section 305 and theright half section are connected to form the external housing 107, theupper left housing 305 a and the upper right housing 306 a form housingopening 106. This opening 106 contains the actuator mechanism 104 andallows it to control the disposable cartridge containing surgical clipsand a plurality of distal end effectors. The internal actuator mechanism104 of the subject invention may be any mechanism, known to thoseskilled in the art, which operates a cartridge containing surgical clipsand a distal end effector that is controllable with pivotable lever 105.

A pivotable lever 105 has a top end 105 a and a bottom end 105 b. Thetop end 105 a of lever 105 is operatively connected to actuatormechanism 104. Trigger shaft 310 is substantially perpendicular to lever105. The top end 105 a of lever 105 may pivot about the pivot point ofbottom end 105 b by rotating around the axis of trigger shaft 310.

Trigger shaft 310 has a left end 310 a and a right end 310 b. Triggershaft bearings 309 are placed over left end 310 a and right end 310 b.

Left end 310 a passes through left opening 305 d of left hinge housing305 and then passes through a spring seal washer 311. A left hingeelement of the trigger 304 has an upper semi-spherical portion 304 awith an indentation 304 b that houses the spring seal washer 311. Afterpassing through spring seal washer 311, left end 310 a of trigger shaft310 attaches within indentation 304 b of the left hinge element of thetrigger 304.

Right end 310 b passes through left opening 306 d of right hinge housing306 and then passes through a spring seal washer 311. A right hingeelement of the trigger 303 has an upper semi-spherical portion 303 awith an indentation 303 b. After passing through spring seal washer 311,right end 310 b of trigger shaft 310 attaches within indentation 303 bof the right hinge element of the trigger 303.

Right hinge element of the trigger 303 has a lower trigger spine 303 cattached to upper semi-spherical portion 303 a. Lower trigger spine 303c has a half-cylindrical shape with a substantially flat face 303 d.

Left hinge element of the trigger 304 has a middle trigger spine 304 cattached to upper semi-spherical portion 304 a. The upper section ofmiddle trigger spine 304 c, proximate to semi-spherical portion 304 a,has a half-cylindrical shape with a substantially flat face 304 d. Thelower section of middle trigger spine 304 c, distal to semi-sphericalportion 304 a, has a substantially cylindrical shape. Left hinge elementof the trigger 304 also has a lower substantially cylindrical triggerspine 304 e attached to middle trigger spine 304 c.

As left end 310 a attaches within indentation 304 b and right end 310 battaches within indentation 303 b, substantially flat face 303 d isattached to the opposing substantially flat face 304 d above the lowersection of middle trigger spine 304 c. Once joined, flat faces 303 d and304 d form a substantially cylindrical shape that is substantiallyequivalent in diameter to the lower section of middle trigger spine 304c. The right hinge element of the trigger 303 is torsionally fixed tothe right end 310 b of trigger shaft 310. The left hinge element of thetrigger 304 is torsionally fixed to the left end 310 a of trigger shaft310.

A hollow substantially cylindrical trigger grip 301 has a top opening301 a and a bottom opening 301 b. The trigger grip 301 is placed overthe connected right hinge element 303 and left hinge element 304 throughtop opening 301 a. The lower trigger spine 304 e of left hinge elementof the trigger 304 passes through bottom opening 301 b, a bushing 307, aretaining ring 308 and is attached to an end cap 302.

FIG. 5 illustrates the rotating trigger in the resting position 103 aand the squeezed position 103 b. When a user applies gripping force tothe trigger grip 301 by squeezing rotating trigger 103, the trigger grip301, the lower trigger spine 303 c, and the middle trigger spine 304 call begin to rotate about the axis of trigger shaft 310 in either aclockwise or counterclockwise direction. As trigger spine 304 c beginsto rotate, the left end 310 a of trigger shaft 310 also begins to rotatein the same direction. Concurrently, as trigger spine 303 c begins torotate, the right end 310 b of trigger shaft 310 also begins to rotatein the same direction. The rotation of trigger shaft 310 causes the topend 105 a of lever 105 to begin to pivot about the about the pivot pointof bottom end 105 b by rotating around trigger shaft 310. The pivotingof top end 105 a operates actuator mechanism 104 which controls thesurgical clip applier distal end effector (not shown). Thus, applicationof gripping force to the trigger 103 operates the surgical clip applier.

Once a user releases the trigger grip 301, the trigger grip 301, thelower trigger spine 303 c, and the middle trigger spine 304 c all beginto rotate about the axis of trigger shaft 310 in the opposite clockwiseor counterclockwise direction The trigger shaft 310 rotating in anopposite direction causes the top end 105 a of lever 105 to begin topivot in an opposite direction about the about the pivot point of bottomend 105 b by rotating around trigger shaft 310. The opposite pivoting oftop end 105 a releases the actuator mechanism 104 which controls thesurgical clip applier distal end effector (not shown). Thus, release ofgripping force to the trigger 103 stops the operation of the surgicalclip applier.

The rotating trigger 103 reduces the gripping force necessary to fullypivot lever 105 to operate actuator mechanism 104 to operate adisposable surgical clip applier (not shown) to fully ligate a vessel orother tissue. In one embodiment of the subject application the grippingforce required to fully actuate for full ligation is reduced from 25 lbsto 5 lbs.

The trigger assembly 101 and the rotating trigger 103 remainhermetically sealed in the resting 103 a and squeezed 103 b positions. Aspring seal washer 311 around the left end 310 a of trigger shaft 310provides a compressive force against semi-spherical portion 304 a and anopposing compressive force against housings 305 a and 305 c. Anotherspring seal washer 311 around the right end 310 b of trigger shaft 310provides a compressive force against semi-spherical portion 303 a and anopposing compressive force against housings 306 a and 306 c. Theseopposing compressive forces on both sides and surrounding trigger shaft310 provide an air seal between trigger 103 and housing 107. This airseal is maintained during rotation of trigger 103 from the resting 103 ato squeezed position 103 b.

Handle and trigger assembly 101 does not require a change of the triggerbody volume inside the handle when the trigger 103 is gripped orreleased. This allows the handle and trigger assembly 101 to contain acompletely air tight seal, making the assembly 101 infinitely reusablewhile reducing sterilization time. This also minimizes autoclaveineffectiveness and the possibility of cross contamination from patientto patient.

In embodiments of the subject invention, the washer seals 311, thebushing 307, the retaining ring 308 and the trigger shaft bearings 309may be composed of titanium, plastic, steel or any combination thereof.In another embodiment of the subject invention, the washer seals 311,the bushing 307, the retaining ring 308 and the trigger shaft bearings309 may all be composed of a unitary construction.

1.-10. (canceled)
 11. A endoscopic surgical tool, comprising: a housing comprising a hermetically-sealed handle assembly; a trigger shaft having a first portion, a second portion, and defining a first axis, the first portion extending through a first opening in the housing, and the second portion extending through a second opening in the housing; a first sealing member disposed and configured to hermetically seal the first portion of the trigger shaft extending through the first opening in the housing; a second sealing member disposed and configured to hermetically seal the second portion of the trigger shaft extending through the second opening in the housing; and a trigger grip operably coupled to the first portion of the trigger shaft and operably coupled to the second portion of the trigger shaft, the trigger grip configured to rotate about a second axis when actuating the endoscopic surgical tool.
 12. The endoscopic surgical tool of claim 11, wherein the first axis and the second axis are substantially perpendicular.
 13. The endoscopic surgical tool of claim 11, wherein the first sealing member and the second sealing member comprise spring seal washers.
 14. The endoscopic surgical tool of claim 11, wherein the first sealing member and the second sealing member comprise disc springs.
 15. The endoscopic surgical tool of claim 11, wherein the housing is nondisposable.
 16. The endoscopic surgical tool of claim 11, wherein the housing comprises a single piece.
 17. The endoscopic surgical tool of claim 11, wherein the housing comprises two coupled pieces with complementary configurations.
 18. An apparatus, comprising: a housing comprising a handle assembly; a trigger shaft, the trigger shaft having a first portion, a second portion, and defining a first axis, the first portion extending through a first opening in the housing, and the second portion extending through a second opening in the housing; and a trigger assembly including and a rotating trigger, the rotating trigger operably coupled to the first portion of the trigger shaft and operably coupled to the second portion of the trigger shaft, the rotating trigger configured to rotate about the first axis.
 19. The apparatus of claim 18, wherein the rotating trigger comprises: a trigger spine operably coupled to the first portion of the trigger shaft and operably coupled to the second portion of the trigger shaft, the trigger spine defining a second axis; and a trigger grip coupled to the trigger spine, the trigger grip disposed and configured to rotate about the second axis defined by the trigger spine.
 20. The apparatus of claim 19, wherein the trigger grip is configured to rotate about the second axis in a clockwise direction or a counterclockwise direction when a force is applied to the trigger grip in a direction towards the handle assembly.
 21. The apparatus of claim 18, further comprising: a first trigger shaft bearing disposed around the first portion of the trigger shaft and coupled to the housing; and a second trigger shaft bearing disposed around the second portion of the trigger shaft and coupled to the housing.
 22. The apparatus of claim 18, further comprising: a first sealing member disposed around the first portion of the trigger shaft; and a second sealing member disposed around the second portion of the trigger shaft.
 23. The apparatus of claim 22, wherein the first sealing member and the second sealing member are configured to prevent bioburden from entering an inner volume.
 24. An apparatus, comprising: a housing comprising a hermetically-sealed handle assembly; a trigger shaft having a first portion, a second portion, and defining a first axis, the first portion extending through a first opening in the housing, and the second portion extending through a second opening in the housing; a first sealing member disposed and configured to hermetically seal the first portion of the trigger shaft extending through the first opening in the housing; a second sealing member disposed and configured to hermetically seal the second portion of the trigger shaft extending through the second opening in the housing; and a trigger assembly operably coupled to the first portion of the trigger shaft and operably coupled to the second portion of the trigger shaft.
 25. The apparatus of claim 24, wherein the first sealing member and the second sealing member provide a force between the housing and the trigger assembly.
 26. The apparatus of claim 25, wherein the first sealing member and the second sealing member comprise disc springs.
 27. The apparatus of claim 25, wherein the first sealing member and the second sealing member comprise spring seal washers.
 28. The apparatus of claim 24, wherein the first sealing member and the second sealing member provide an air seal between the housing and the trigger assembly.
 29. The apparatus of claim 24, wherein the first sealing member and the second sealing member are configured to prevent bioburden from entering an inner volume of the housing.
 30. The apparatus of claim 24, wherein the trigger assembly includes a rotating trigger, the rotating trigger operably coupled to the first portion of the trigger shaft and operably coupled to the second portion of the trigger shaft, the rotating trigger configured to rotate about the first axis.
 31. The apparatus of claim 30, wherein the rotating trigger comprises: a trigger spine operably coupled to the first portion of the trigger shaft and operably coupled to the second portion of the trigger shaft, the trigger spine defining a second axis, and a trigger grip coupled to the trigger spine, the trigger grip disposed and configured to rotate about the second axis defined by the trigger spine, wherein the trigger grip is configured to rotate about the second axis in a clockwise direction or a counterclockwise direction when a force is applied to the trigger grip in a direction towards the handle assembly. 